Prospective Randomized Evaluation of DIabetics for graft patency and outcomes following Coronary artery bypass grafting using one (single) versus two or More (mulTi) arterial grafts (PREDICT) trial

OBJECTIVE: As the result of procedural complexity and risk of sternal wound infections, the adoption of multiarterial grafting (MAG) in coronary artery bypass surgery is lower in patients with diabetes despite a high prevalence of multivessel coronary artery disease. We conducted a randomized controlled study to evaluate the safety, graft patency at 1 year, and long-term survival at 5 years in MAG compared to single arterial grafting (SAG). This interim analysis reports 1-year mortality, morbidity, and graft patency. METHODS: A total of 950 patients with diabetes and multivessel coronary artery disease were enrolled between February 2022 and January 2025 at 15 hospitals across 7 states in India and randomized to SAG (n = 477) or MAG (n = 473) groups in a multicenter, prospective, randomized trial. Major adverse cardiac and cerebrovascular events and graft patency assessed by computed tomography coronary angiography at 1 year were analyzed (CTRI/2020/09/027692). RESULTS: One-year composite outcome (SAG: n = 7 [1.5%] vs MAG: n = 7 [1.5%], P = .98) and mortality (SAG: n = 4 [0.8%] vs MAG: n = 6 [1.3%], P = .51) were low and comparable. Myocardial infarction occurred in 1 patient in each group. Stroke rates were comparable (SAG: n = 2 vs MAG: n = 1). One patient with SAG required repeat revascularization (percutaneous coronary intervention). Sternal wound infection occurred in 7 patients in the SAG group (1.5%) and 12 patients in the MAG group (2.6%) (P = .36). Sternal reconstruction was required in only 3 patients in the MAG group (0.6%). In total, 350 patients underwent protocol computed tomography graft angiography for graft assessment (SAG: n = 170, MAG: n = 180). Although overall graft patency did not differ between the SAG and MAG groups, vein graft patency was greater with MAG only after statistical adjustment for the effect of on-pump or off-pump status and involved coronary artery. Off-pump coronary artery bypass surgery, right internal mammary artery grafts, and right coronary artery and left circumflex coronary artery territory grafting were associated with lower overall graft patency. CONCLUSIONS: Interim results from the trial demonstrate similar safety and 1-year clinical outcomes for SAG and MAG. We show superior venous graft patency with MAG after adjustment, but additional studies are required to validate this finding.